SYNAREL 2 MG/ML NASAL SPRAY SOLUTION

Transcript

Synarel

®

2mg/ml Nasal Spray
Nafarelin acetate

What is in this leaflet
1. What Synarel is and what it is used for
2. What you need to know before you take Synarel
3. How to take Synarel
4. Possible side effects
5. How to store Synarel
6. Contents of the pack and other information
1. What Synarel is and what it is used for

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Important things that you SHOULD know about your
medicine:
• SYNAREL is for the treatment of endometriosis or as
part of a supervised fertility programme and is for use
by women only.
• This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
• You should take SYNAREL regularly as instructed by
your doctor or nurse, in order for it to be effective.
• Most people do not have serious problems when taking
SYNAREL but side effects can occur – see Section 4
for details. If any of the side effects gets serious, or if
you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
• Taking other medicines may sometimes cause
problems. Check with your doctor or pharmacist before
taking this or any other medicines.
Please read the rest of this leaflet. It includes other
important information on the safe and effective use of
this medicine that might be especially important to you.
If you have any further questions, ask your doctor or
pharmacist. This leaflet was last updated in 01/2016

PACKAGE LEAFLET: INFORMATION FOR THE USER

Synarel works by reducing the normal response of your body
to a hormone called GnRH (gonadotrophin releasing
hormone). As a result, your ovaries produce less of another
hormone called oestrogen. You will notice the reduced amount
of oestrogen usually by your periods either stopping or being
reduced in amount after about one month of taking Synarel.
Synarel has to get into your blood stream before it can
work. This cannot happen if it is taken by mouth, because
your stomach acid will break it down and it will be
digested. Therefore, nasal inhalation is a simple way to get
this medicine into your blood stream.
Synarel is used to treat endometriosis. It can also be
prescribed with other medicines for women trying to become
pregnant as part of a supervised fertility programme.
2. What you need to know before you take Synarel

` Do not use Synarel
• If you are allergic to Synarel, gonadotrophin releasing
hormone or any of the other ingredients of this
medicine (listed in section 6).
• If you are pregnant or may become pregnant whilst
taking Synarel. If you are taking Synarel as part of a
fertility programme, your pregnancy will be planned to
take place after you stop taking this medicine.
• If you suffer from vaginal bleeding, for which your
doctor could not find the cause.

• If you are currently breast-feeding.
• If you are under 18 years of age.

` Warnings and precautions
Talk to your doctor or pharmacist before using Synarel
• If you suffer from Polycystic Ovarian Disease as there
is a potential risk for excessive follicular stimulation
• If you think you might be pregnant there is a risk to
the development of the foetus and/or miscarriage.
• There have been reports of depression in patients
taking Synarel which may be severe. If you are taking
Synarel and develop depressed mood, inform your
doctor.
Your doctor will advise whether you can still take Synarel.
` Other medicines and Synarel
Tell your doctor or pharmacist if you are using, have recently
used, or might use any other medicines.
Nasal decongestants should not be used within the 30
minute period before taking a dose of Synarel as they can
significantly reduce absorption of the medicine in the nose. If
your nose is congested, Synarel will still be absorbed.
If you have been using an oral contraceptive to prevent
pregnancy, your doctor will ask you to stop taking these
and use a barrier method of contraception (diaphragm,
condom) to stop you becoming pregnant.
` Synarel with food and drink
Synarel can be taken with or without food.
` Pregnancy, breast-feeding and fertility
Do not take Synarel if you are pregnant or trying to
become pregnant.
Do not take Synarel if you are breast-feeding.

` Driving and using machines
Synarel is not known to affect the ability to drive or use machinery.
` Synarel contains benzalkonium chloride
Benzalkonium chloride (a type of preservative) is an
irritant and may cause skin reactions, swelling and
bronchospasm.
3. How to use Synarel

Always use this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
` How to use your medicine
For endometriosis: the usual dose is one spray twice
each day for six months. Spray into one nostril in the
morning, and the other nostril in the evening (a total of 2
sprays per day). You should use the spray for the first time
between the second and fourth day of your period.
For endometriosis, the longest time for which you should
be taking your medicine is 6 months.
For use in fertility programmes: if you are taking this
medicine as part of a fertility programme, the dose is
usually one spray to both nostrils in the morning, and one
spray to both nostrils in the evening (4 sprays per day).
If you are taking this medicine as part of a fertility programme,
your doctor will tell you how long to keep taking your medicine.
This will usually be for no longer than 8 weeks.
Take your spray as your doctor has told you to. If you are still
not sure, ask your doctor or pharmacist.
It is important to keep taking your spray.
If you have any questions, don't wait until your nasal spray
is finished before seeing your doctor.

Priming the Spray Pump: Before you use a bottle of
Synarel for the first time, you have to prime the spray
pump. This only needs to be done once, before you take
your first dose.
1. Remove the safety clip and the
plastic dust cap to uncover the nasal
piece. Hold the bottle with two fingers
on the 'shoulders' and your thumb on
the bottom of the bottle.
2. Prime the pump by pressing the
bottle upwards several times firmly
and quickly until the air is expelled
and a fine spray appears. This
usually requires about 5 - 7 presses.
It is not necessary to prime the pump
again during subsequent use.

3. Clean the tip of pump. Hold the
bottle in a horizontal position and
rinse the spray tip with warm water,
while wiping the tip with your finger or
a clean soft cloth.
Do not clean the spray tip with a
pointed object. This could cause an
improper dose of the spray to be
delivered. Do not remove the pump
from the bottle, as this will release
the priming pressure.
Wipe the tip dry with a clean soft
cloth or tissue.
4. Bend head forward slightly. Close
one nostril and put the spray tip into
the other, aiming towards the back
and outer side of your nose.

Using the Spray Pump
1. Gently blow your nose to clear the
nostrils.

5. Press the bottle firmly up between
thumb and fingers once only whilst
gently breathing in through the
nostril. If your doctor has told you to
take 4 sprays every day, now spray
into your other nostril.

2. Remove the safety clip and the
plastic cap to uncover the nasal
piece. Hold the bottle as shown
previously.

6. Remove the sprayer from the
nostril. Bend head backwards for a
few seconds to let the spray spread
over back of the nose.

7. Clean the tip of pump. Hold the
bottle in a horizontal position and
rinse the spray tip with warm water,
while wiping the tip with your finger or
a clean soft cloth.
Do not clean the spray tip with a pointed
object. This could cause an improper
dose of the spray to be delivered. Do
not remove the pump from the bottle, as
this will release the priming pressure.
Wipe the tip dry with a clean soft
cloth or tissue.
Cleaning the spray tip before and
after use is important to prevent
clogging of the tip.
8. Replace the safety clip and the
plastic dust cap on the nasal piece.

If you use more Synarel than you should
• If you have taken too many sprays at once, or in one
day contact your doctor or go to your nearest hospital
casualty department immediately.
If you forget to use Synarel
• If you forget to take your spray at the proper time, take
it as soon as you remember and take the next spray at
your normal time. Do not take a double dose to make
up for a forgotten dose.

• If you miss one or more doses, vaginal bleeding (often
called breakthrough bleeding) may occur. Also, release
of an egg from the ovary (ovulation) may occur. If you
have had sexual intercourse and not used
contraception, you could become pregnant. It is then
important that you stop taking Synarel and see your
doctor to make sure that you are not pregnant. (This is
why it is very important to use a barrier method of
contraception when you are taking this medicine.).
• Take your spray as your doctor has told you to.
• If you are still not sure, ask your doctor or pharmacist.
• It is important to keep taking your spray.
• If you have any questions, don't wait until your nasal
spray is finished before seeing your doctor.
4. Possible side effects

Like all medicines, Synarel can cause side effects
although not everybody gets them.
Stop taking Synarel and tell your doctor straight away if
you have an allergy to this medicine. If you are allergic to
it, you may become short of breath, have chest pain, or a
rash which may or may not be itchy.
Other side effects Synarel may cause are listed below by
frequency:
Very common side effects: may affect more than 1 in 10
people
• weight increase
• swings of emotion
• sex drive decrease
• headache
• hot flushes
• nasal irritation and/or inflammation
• acne
• oily appearance on the skin and the formation of
grease scales
• painful muscles
• breast size decrease

Not known side effects: the frequency cannot be estimated
from the available data
• migraine
• blurred vision
• palpitations
• liver enzyme increases
• short term increase in symptoms of endometriosis
Tell your doctor if you are due to have any medical tests
as the results may be affected.

If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet.

5. How to store Synarel

• You should always put the safety clip and the plastic
dust cap back on when you are not using the medicine.
• Keep your spray out of the reach and sight of children.
• Do not use Synarel after the expiry date which is stated
on the carton after EXP. The expiry date refers to the
last day of that month.
• Do not store above 25°C and protect from freezing.
• Keep the bottle upright and store away from light.
• Do not throw away any medicines via household
waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will
help protect the environment.

6. Contents of the pack and other information
What Synarel contains and its package:
The active substance is nafarelin acetate. The Synarel
spray liquid contains nafarelin acetate equivalent to a
concentration of 2 mg/ml nafarelin in a bottle fitted with a
metered spray pump. Each actuation of the spray pump
delivers 200 micrograms of nafarelin.
The other ingredients in the spray liquid are:
• Sorbitol, benzalkonium chloride, glacial acetic acid,
water; and
• Sodium hydroxide or hydrochloric acid to adjust the
acidity.
Synarel is available in white, high density polyethylene
bottles with a 0.1ml metered spray pump, containing 6.5ml
(30 sprays) or 10ml (60 sprays). Synarel is also available in
PVC-coated glass bottles with an internal conical reservoir in
the base and a valois pump, with either an aluminium crimpon cap or a polypropylene snap-on cap, containing 4ml (30
sprays) or 8ml (60 sprays). These are designed to deliver 30
or 60 sprays respectively (as stated on the pack) and should
be disposed of once they have been used for the appropriate
number of spray applications.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.